Market Place
Phispers brings you the latest in global pharma
news, such as how the drug price hike uproar in the US is affecting Sun Pharma,
how the UN may adopt a resolution on fighting the menace of antibiotic
resistance and how bioelectronics is working towards improving diabetes care.
And there is more on Zhejiang Hisun, Novartis and GSK. Import alert on
Zhejiang Hisun continues to haunt the FDAA little over a month ago, Bloomberg highlighted the challenges of banning China’s Zhejiang Hisun. This week, the FDA had to exempt even more
products to ensure supply sustainability in the United States. In addition to the 14
drugs which were exempted when the initial import alert was announced, Sulbactam Sodium and Mesna have now been excluded from the import alert list.The FDA had issued an indefinite
ban on the Zhejiang Hisun factory. Yet, in order to avoid possible shortages of
drugs, the FDA allowed the plant to continue to export 15 ingredients
for use in finished drugs in the US, including nine key cancer medicine
components. In the US, more than 80 percent of drug ingredients are produced overseas, in mainly China and India. The FDA has stepped up inspections in order to check quality. However, it relies on pharmaceutical companies to ensure the ingredients are up to the US standards. Sun Pharma’s unit gets summoned for price gouging in the USThe ripples of the
ongoing uproar in the US over high drug prices can be felt in India. Last week,
the US Department sent grand jury subpoenas to Sun Pharmaceutical Industries’ unit – Taro Pharmaceuticals. In a statement to the
Securities Exchange Commission, Taro said two of its commercial executives in
its US unit were summoned by the antitrust division of the Department of
Justice (DOJ). The DOJ sought “communications with competitors and others” regarding the sale of generic drugs. Taro contributed US $ 230 million to Sun Pharma’s US $ 375 million revenue from the US last year.According to a news report, Taro has received notice for raising the
price on clobetasol – a steroid that is sold as a topical ointment, cream, and gel – substantially between July 2011 and June 2014. The price of 15 grams of 0.05 percent topical ointment increased from US $5.75 to US $124.36 during the period, according to Truven Health Analytics. UN General Assembly
to take up antibiotic resistance next weekNext week, we will know whether combatting the menace of antibiotic
resistance will become an international priority or not. The United Nations
will open its two-week long General Assembly in New York next week, where it
will debate issues of global importance. On September 21, the assembly will host a “high-level meeting” on the threat of resistant bacteria. The assembly will showcase presentations from
representatives of governments and non-profit and academic organizations. The same day, the UN is expected to adopt its first-ever resolution on
the importance of combating antibiotic resistance, and perhaps also some sort
of a commitment to action.According to estimates, antibiotic resistance kills 700,000 people around
the globe each year, with 23,000 people dying each year in the US and 25,000 in
Europe. After Novartis and
GSK, Google now ties up with Sanofi This week, there was
some big news in the field of bioelectronics, a novel field of medicine that is
focused on fighting diseases by targeting electrical signals in the body. Sanofi and Verily (the life sciences unit of Google parent Alphabet) announced they would
invest about US $ 500 million in a joint venture combining devices with
services to improve diabetes care.The deal with the
French drug maker Sanofi comes after British drug
maker GlaxoSmithKline (GSK) and Verily
created a new bioelectronics company. Verily is also working on the development of a smart
contact lens in partnership with Swiss drug maker Novartis that has an embedded glucose sensor to help monitor
diabetes. These partnerships are examples of growing
ties between the pharma and tech sectors.There was more positive news from Sanofi. Last week,
it received positive data from a Phase III study of their diabetes drug sotagliflozin. Considered the next-gen
improvement on the SGLT2 (sodium/glucose cotransporter 2) inhibitors, investigators say that two doses of sotagliflozin were able to reduce
A1C levels by 0.43 percent and 0.49 percent in patients
with type 1 diabetes. GSK sells anesthetic drugs to South Africa’s Aspen for US $ 370 millionAs part of its drive
to focus on core therapy areas, British drug maker GlaxoSmithKline is selling its
portfolio of anesthetic drugs to South Africa's Aspen Pharmacare for around US $ 372 million (GBP 280 million).On Monday, the two
companies announced that Aspen would pay GBP 180 million (US $ 238 million) for
the products Ultiva, Nimbex, Tracrium, Mivacron and Anectinein, and an additional GBP 100 million (US $ 132
million) in milestone payments. The two firms have a long history of working
together. GSK has already sold
the US and Canadian rights to these drugs. The company earned around GBP 35
million (US $ 46 million) from the anaesthetics in the first half of 2016. Novartis finds ECA
support in its battle over ban on toxic chemicalNovartis recently received significant support from the
European Chemicals Agency in its battle over diglyme – a toxic chemical that Novartis used for making an ingredient found in two medicines.Last month, the ECA
decided to support a Novartis request for a seven-year exemption from a pending
ban on diglyme. The chemical is used to make indacaterol, an ingredient in treatments for chronic
obstructive pulmonary disorder. The ban goes into effect in August 2017.A final decision,
however, will be made by the European Commission. And, it is unclear when the
decision will be made. However, a leading environment group – ChemSec -- has urged ECA to support the ban. ChemSec had insisted the ban should be upheld due to “socio-economic” costs associated with continued use of the chemical, as well as negative consequences for companies that produce potential alternatives.
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https://www.pharmacompass.com/radio-compass-blog/fda-haunted-by-problems-at-chinese-plant-sun-pharma-gets-entangled-in-price-gouging-furor
#PharmaFlow by PHARMACOMPASS
15 Sep 2016
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